Device recall
Z-1985-2012: InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing…
FDA device recall · Class I · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-1985-2012 |
|---|---|
| Recall event | 62112 |
| Product | InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit… |
| Product code | LLZ |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 21, 2012 |
| 510(k) numbers | K040050 |
| FEI number | 1720753 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database